This study is a prospective, randomized, controlled study, which intends to enroll patients with suspected early-stage NSCLC (non-small cell lung cancer) with a diameter of ≤ 3 cm as research subjects. The study is conducted in accordance with the Declaration of Helsinki. It has been approved by the Ethics Committee of the Second Affiliated Hospital of Air Force Medical University, and patients or their family members have signed the informed consent form. Patients undergoing VATS (video-assisted thoracic surgery) are enrolled in the Department of Thoracic Surgery of the Second Affiliated Hospital of Air Force Medical University. The patients are randomly divided into two groups: the NIVATS (non-intubated video-assisted thoracic surgery) group and the OLV (one-lung ventilation) group. By observing various perioperative indicators of the patients, the short-term efficacy of the two techniques in patients with early-stage NSCLC is compared, so as to evaluate the safety and effectiveness of the NIVATS surgical treatment method.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
410
NIVATS is a special method developed in the past two decades. It means that patients do not undergo tracheal intubation under general anesthesia during the entire surgical process, retaining their spontaneous breathing, but supraglottic airway devices (such as laryngeal masks, high-flow nasal catheters, mask ventilation) can be used to support their breathing. The purpose of this technology is to minimize the impact of general anesthesia, tracheal intubation, mechanical ventilation, etc. on patients.
Average postoperative hospital stay
Time frame: up to 3 months
Intraoperative opioid consumption
Time frame: 1 day
Lung collapse score
Time frame: 1 day
Intraoperative blood gas analysis (Q1h)
Time frame: 1 day
Conversion to intubation rate
Time frame: 1 day
Postoperative awakening time
Time frame: 1 day
Time to first ambulation after surgery
Time frame: up to 3 months
Ambulation rate within 4 hours after surgery
Time frame: up to 3 months
Inflammatory markers (IL-6, peripheral neutrophil-to-lymphocyte ratio)
Time frame: up to 3 months
Postoperative drainage volume
Time frame: up to 3 months
Incidence of perioperative complications
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: up to 3 months
15 item Quality of Recovery Rating Scale (QoR-15)
Time frame: up to 1 year
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